FDA Inspection
Foulk & Whitten Nevada Center For Reproductive MedicineFoulk & Whitten Nevada Center For Reproductive Medicine – FDA Inspection, Mar 28, 2019
Record Details
This FDA Inspection record concerns Foulk & Whitten Nevada Center For Reproductive Medicine, with an inspection on March 28, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 28, 2019
- Product Type
- Biologics
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ID · b0a921cc-3399-492b-b75f-2135284d0b23
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084676
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
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Other FDA inspections of Foulk & Whitten Nevada Center For Reproductive Medicine
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 16, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 5, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 31, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 6, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Foulk & Whitten Nevada Center For Reproductive Medicine
- FDA Inspection 1223875 - 2023-11-15
- FDA Inspection 993202 - 2016-11-16
- FDA Inspection 883672 - 2014-06-05
- FDA Inspection 727117 - 2011-05-31
- FDA Inspection 583033 - 2009-05-06
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